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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005570
Receipt No. R000006594
Scientific Title Can abatacept induce immunological remission under tight control in rheumatoid arthritis patient?
Date of disclosure of the study information 2011/06/01
Last modified on 2012/11/28

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Basic information
Public title Can abatacept induce immunological remission under tight control in rheumatoid arthritis patient?
Acronym Airtight study
Scientific Title Can abatacept induce immunological remission under tight control in rheumatoid arthritis patient?
Scientific Title:Acronym Airtight study
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether abatacept brings immunological remission to patients with rheumatoid arthritis under the environment where disease activity is controlled tightly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Changes in values of anti-cyclic citrullinated peptide antibody, rheumatoid factor, IgG that lack galactose, and type IgG rheumatoid factor
Key secondary outcomes Scores in joint echo for hand and wrist

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who had a diagnosis by 2010 ACR/EULAR rheumatoid arthritis classification criteria and then will receive one of biological agents
Including patients with switching of biologic agents
Key exclusion criteria Patients with leukocyte less than 4000/mm3, lymphocytes 1000/mm3, ADL activity in class IV, interstitial pneumonia, active hepatitis B, active tuberculosis, compromised condition, malignant tumor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Department of Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3984
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Dept. of orthopaedic surgery
Zip code
Address
TEL
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Department of Rheumatosurgery, Osaka City University Medical School
Institute
Department

Funding Source
Organization Department of Rheumatosurgery, Osaka City University Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学医学部附属病院(大阪)、東住吉森本病院(大阪)、北出病院(和歌山)、白浜はまゆう病院(和歌山)、大東中央病院(大阪)、十三市民病院(大阪)、藤井寺市民病院(大阪)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 07 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information Before and after one year of administration of biologic agents we perform the immunological tests such as anti-CCP antibodies to patients with rheumatoid arthritis who will receive biologics after May, 2011. Because there is a case which synovial local activity cannot be controlled even if it is the patients who arrived at the clinical remission, we perform the joint echo on hands and do it with the help of the judgment of the remission.

Management information
Registered date
2011 Year 05 Month 08 Day
Last modified on
2012 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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